510(k) · Cleared
ClearedCarematix Wellness System, Model CWS-5000.1-B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carematix, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jan 11, 2008 as substantially equivalent to K040966 (Carematix, Inc., 2004) after a 74-day review. Its family tree reaches back 7 generations to 1987. 6 later devices descend from it.
- Decided
- Jan 11, 2008
- Review
- 74 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K864318 (1987). 18 ancestors in all, the oldest K790130 (1979). 6 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 6 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 5 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 4 generations backK993169 Modification of: Physiological Signal Transmitter and Receiver…Hewlett-Packard Co. · 1999
- 3 generations backK023749 The M3810A Philips Telemonitoring System with M3812B Telestation…Philips Medical Systems · 2002
- 2 generations backK031840 Carematix Wellness SystemCarematix, Inc. · 2003
- 1 generation backK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
- This deviceK073038 Carematix Wellness System, Model CWS-5000.1-BCarematix, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK100508 Carematix Wellness System, Model CWS-5000.1-BCarematix, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK103796 Telemedcare Health MonitorTelemedcare Pty, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK101078 BL Healthcare Remote Care Management SystemBl Healthcare, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK122333 Mobilecare MonitorAframe Digital, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK113493 TCX-I Remote Care Management SystemBl Healthcare, Inc. · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K100508Carematix Wellness System, Model CWS-5000.1-BCarematix, Inc. · 2010 · cites it directly2descendants
- K103796Telemedcare Health MonitorTelemedcare Pty, Ltd. · 2011 · cites it directly1descendant
- K101078BL Healthcare Remote Care Management SystemBl Healthcare, Inc. · 2010 · cites it directly1descendant
- K122333Mobilecare MonitorAframe Digital, Inc. · 2012 · 2 generations on0descendants
- K113493TCX-I Remote Care Management SystemBl Healthcare, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −6 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −5 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −4 | K993169 | Modification of: Physiological Signal Transmitter and Receiver, Model 3810A | Hewlett-Packard Co. | 1999 | — |
| −3 | K023749 | The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) | Philips Medical Systems | 2002 | — |
| −2 | K031840 | Carematix Wellness System | Carematix, Inc. | 2003 | — |
| −1 | K040966 | Modification to Carematix Wellness System | Carematix, Inc. | 2004 | — |
| 0 (this device) | K073038 | Carematix Wellness System, Model CWS-5000.1-B | Carematix, Inc. | 2008 | — |
| +1 | K100508 | Carematix Wellness System, Model CWS-5000.1-B | Carematix, Inc. | 2010 | — |
| +1 | K103796 | Telemedcare Health Monitor | Telemedcare Pty, Ltd. | 2011 | — |
| +1 | K101078 | BL Healthcare Remote Care Management System | Bl Healthcare, Inc. | 2010 | — |
| +2 | K122333 | Mobilecare Monitor | Aframe Digital, Inc. | 2012 | — |
| +2 | K113493 | TCX-I Remote Care Management System | Bl Healthcare, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040966 | Modification to Carematix Wellness SystemSummary page 1…DRG Classification Panel: Cardiovascular Device Panel Regulation Number: 21 CFR 870.2910 Predicate Devices K040966 CarematixTM Wellness System CarematixTM, Inc. Description of Device The CarematixTM Wellnes… | 2004 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K100508 (Carematix, Inc., 2010) has gone furthest, with 2 descendants of its own.
- 15 other devices also cite its predicate K040966.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The CarematixTM Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as: Non-invasive blood pressure measurement; Pulse rate measurement; Blood glucose level using a…
Read the full statement (140 words)
The CarematixTM Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as:
Non-invasive blood pressure measurement;
Pulse rate measurement;
Blood glucose level using a Glucometer;
Blood hemoglobin oxygen saturation (%SPO2) using a digital Pulse Oximeter;
Prothrombin Time (PT) and International Normalized Ratio (TNR) measurement using an in-home coagulation measurement system;
Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter;
Patient weight using a stand-on electronic scale
The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073038 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073038: Carematix Wellness System, Model CWS-5000.1-B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073038
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026